Interest in and Preference for Long-acting Injectable Antiretroviral Therapy in the Era of Approved Cabotegravir/Rilpivirine among Reproductive-aged Women in the U.S. South.

Among 103 reproductive-aged women with HIV in the U.S. South surveyed post-approval of long-acting injectable (LAI) cabotegravir/rilpivirine, nearly two-thirds reported willingness to try LAI antiretroviral therapy (ART). Most expressed preference for LAI over daily oral ART and had minimal concerns over potential LAI-ART use impacting reproductive health.

A mixed methods evaluation assessing the feasibility of implementing a PrEP data dashboard in the Southeastern United States.

BACKGROUND: Alabama is one of seven priority states for the National Ending the HIV Epidemic Initiative due to a disproportionate burden of rural infections. To reverse growing infection rates, the state must increase its focus on prevention efforts, including novel strategies. One such approach is to utilize dashboards that visualize real-time data on the pre-exposure prophylaxis (PrEP) care continuum to assist in prioritizing evidence-based preventative care for those most vulnerable for HIV infection. METHODS: We conducted a mixed methods evaluation to ascertain stakeholders' perceptions on the acceptability, feasibility, appropriateness, and usability of a PrEP care continuum dashboard, as well as gain insight on ways to improve the activities necessary to sustain it. Clinicians, administrators, and data personnel from participating sites in Alabama completed surveys (n = 9) and participated in key informant interviews (n = 10) to better understand their experiences with the prototype data dashboard and to share feedback on how it can be modified to best fit their needs. RESULTS: Surveys and interviews revealed that all participants find the pilot data dashboard to be an acceptable, feasible, and appropriate intervention for clinic use. Overall, stakeholders find the pilot dashboard to be usable and helpful in administrative efforts, such as report and grant writing; however, additional refining is needed in order to reduce burden and optimize usefulness. Participants voiced concerns about their site's abilities to sustain the dashboard, including the lack of systematized PrEP protocols and limited funds and staff time dedicated to PrEP data collection, cleaning, and upload. CONCLUSION: Study participants from clinics providing HIV prevention services, including PrEP, in Alabama voiced interest in sustaining and refining a data dashboard that tracks clients across the PrEP care continuum. Despite viewing the platform itself as an acceptable, feasible, and appropriate intervention, participants agreed that efforts need to be focused on standardizing PrEP data collection protocols in order to ensure consistent, accurate data capture and that limited funds and staff time are barriers to the sustained implementation of the dashboard in practice.

Role of Visit Modality in the HIV-Related No-Shows During the COVID-19 Pandemic: A Multisite Retrospective Cohort Study.

The emergence of the COVID-19 pandemic necessitated rapid expansion of telehealth as part of healthcare delivery. This study compared HIV-related no-shows by visit type (in-person; video; telephone) during the COVID-19 pandemic (April 2020-September 2021) from the Data for Care Alabama project. Using all primary care provider visits, each visit's outcome was categorized as no-show or arrived. A logistic regression model using generalized estimating equations accounting for repeat measures in individuals and within sites calculated odds ratios (OR) and their accompanying 95% confidence interval (CI) for no-shows by visit modality. The multivariable models adjusted for sociodemographic factors. In-person versus telephone visits [OR (95% CI) 1.64 (1.48-1.82)] and in-person versus video visits [OR (95% CI) 1.53 (1.25-1.85)] had higher odds of being a no-show. In-person versus telephone and video no-shows were significantly higher. This may suggest success of telehealth visits as a method for HIV care delivery even beyond COVID-19.

Assessing the Impact of COVID-19 on Retention in HIV Primary Care: A Longitudinal Multisite Analysis.

We compared retention in care outcomes between a pre-COVID-19 (Apr19-Mar20) and an early-COVID-19 (Apr20-Mar21) period to determine whether the pandemic had a significant impact on these outcomes and assessed the role of patient sociodemographics in both periods in individuals enrolled in the Data for Care Alabama project (n = 6461). Using scheduled HIV primary care provider visits, we calculated a kept-visit measure and a missed-visit measure and compared them among the pre-COVID-19 and early-COVID-19 periods. We used logistic regression models to calculated odds ratios (OR) and accompanying 95% confidence intervals (CI). Overall, individuals had lowers odds of high visit constancy [OR (95% CI): 0.85 (0.79, 0.92)] and higher odds of no-shows [OR (95% CI): 1.27 (1.19, 1.35)] during the early-COVID-19 period. Compared to white patients, Black patients were more likely to miss an appointment and transgender people versus cisgender women had lower visit constancy in the early-COVID-19 period.

Development and implementation of a distributed data network between an academic institution and state health departments to investigate variation in time to HIV viral suppression in the Deep South.

BACKGROUND: Achieving early and sustained viral suppression (VS) following diagnosis of HIV infection is critical to improving outcomes for persons with HIV (PWH). The Deep South of the United States (US) is a region that is disproportionately impacted by the domestic HIV epidemic. Time to VS, defined as time from diagnosis to initial VS, is substantially longer in the South than other regions of the US. We describe the development and implementation of a distributed data network between an academic institution and state health departments to investigate variation in time to VS in the Deep South. METHODS: Representatives of state health departments, the Centers for Disease Control and Prevention (CDC), and the academic partner met to establish core objectives and procedures at the beginning of the project. Importantly, this project used the CDC-developed Enhanced HIV/AIDS Reporting System (eHARS) through a distributed data network model that maintained the confidentiality and integrity of the data. Software programs to build datasets and calculate time to VS were written by the academic partner and shared with each public health partner. To develop spatial elements of the eHARS data, health departments geocoded residential addresses of each newly diagnosed individual in eHARS between 2012-2019, supported by the academic partner. Health departments conducted all analyses within their own systems. Aggregate results were combined across states using meta-analysis techniques. Additionally, we created a synthetic eHARS data set for code development and testing. RESULTS: The collaborative structure and distributed data network have allowed us to refine the study questions and analytic plans to conduct investigations into variation in time to VS for both research and public health practice. Additionally, a synthetic eHARS data set has been created and is publicly available for researchers and public health practitioners. CONCLUSIONS: These efforts have leveraged the practice expertise and surveillance data within state health departments and the analytic and methodologic expertise of the academic partner. This study could serve as an illustrative example of effective collaboration between academic institutions and public health agencies and provides resources to facilitate future use of the US HIV surveillance system for research and public health practice.

COVID Community-Engaged Testing in Alabama: Reaching Underserved Rural Populations Through Collaboration.

Rural communities are often underserved by public health testing initiatives in Alabama. As part of the National Institutes of Health's Rapid Acceleration of Diagnostics‒Underserved Populations initiative, the University of Alabama at Birmingham, along with community partners, sought to address this inequity in COVID-19 testing. We describe the participatory assessment, selection, and implementation phases of this project, which administered more than 23 000 COVID-19 tests throughout the state, including nearly 4000 tests among incarcerated populations. (Am J Public Health. 2022;112(10):1399-1403. https://doi.org/10.2105/AJPH.2022.306985).

Evaluation of peer-to-peer HIV counseling in Myanmar: a measure of knowledge, adherence, and barriers.

In Myanmar, an Asian country with one of the highest HIV-1 prevalence rates, counseling prior to initiating antiretroviral therapy (ART) is standard care, either by a healthcare worker (standard counselor, SC) or trained counselor who is also living with HIV (peer counselor, PC). PC is commonly utilized in Myanmar and other resource-limited settings. However, its benefit over SC is unclear. We conducted a cross-sectional survey of people living with HIV (PLWH), who completed either only PC or only SC before treatment initiation across four cities in Myanmar. Participants were evaluated for HIV knowledge, stigma, antiretroviral adherence, barriers to care, social support satisfaction and attitudes regarding both counseling processes. Bivariate analyses and multivariable mixed effects modeling were conducted to compare differences in these measures among PC and SC participants. Among 1006 participants (49% PC; 51% SC), 52% were females and median age was 37 years in those receiving PC and 40 years in those receiving SC. More than 70% of participants in both groups achieved up to grade school education. The average duration since HIV diagnosis was 4.6 years for PC and 5.7 years for SC participants. HIV knowledge and attitudes regarding counseling were good in both groups and more PC participants credited their HIV counselor for knowledge (75% vs 63%, p < 0.001). Compared to SC, PC participants had lower enacted stigma (Incidence Rate Ratio (IRR) 0.75, Confidence Interval (CI) [0.65, 0.86]), mean internalized stigma (-0.24, CI [-0.34, -0.14]), and risk of antiretroviral therapy non-adherence (Odds Ratio 0.59, CI [0.40, 0.88]), while reporting higher levels of barriers to care (9.63, CI [8.20, 11.75]). Our findings demonstrate potential benefits of PC compared to SC, and support the utilization of PC to enhance HIV health outcomes within the unique societal and geographical context of Myanmar, and possibly beyond.

Telephone-Delivered Mindfulness Training for People Living with HIV: A Qualitative 360° Inquiry.

For people living with HIV and AIDS (PLWHA), life stress often undermines quality of life and interferes with medical care. Mindfulness training (MT) may help PLWHA to manage stress. Because standard MT protocols can be burdensome, we explored telephone delivery as a potentially more feasible approach. We used an innovative 360° qualitative inquiry to seek input regarding telephone-delivery of MT for PLWHA in advance of a planned intervention trial. We also sought input on a time- and attention-matched control. Twenty five HIV patients, providers and advocates, were recruited to five focus groups. Participants understood the construct of mindfulness and recognized its potential benefits for stress management and improving medication adherence. Patients preferred the term "mindfulness" to meditation. Telephone-delivery appealed to all patients but several challenges were raised. Topics for the control intervention included nutrition, sleep, and aging. The 360° approach allowed three groups (patients, providers, advocates) to influence intervention development.

Pregnancy Desire, Partner Serodiscordance, and Partner HIV Disclosure among Reproductive Age HIV-Infected Women in an Urban Clinic.

Women comprise 25% of the US HIV epidemic, with many women of reproductive age. There is a need for providers to address the reproductive needs and desires of women with HIV given that effective antiretroviral therapy has transformed HIV into a chronic disease. This cross-sectional study shows high rates of partner serodiscordance (61%) and moderate HIV disclosure to partners (61%). Patients surveyed reported practitioners discuss condoms (94%) and contraception (71%) more often than pregnancy desire (38%). In our sample, 44% of the surveyed women intended future pregnancy, whereas women who did not intend future pregnancy cited HIV/health and serodiscordance as the most common reasons (56% and 35%, resp.). There was no difference in the knowledge of mother-to-child transmission risk between women who intended or did not intend future pregnancy (p = 0.71). These results underline the need for provider training in reproductive counseling to promote risk reduction and education.

Differences in antiretroviral safety and efficacy by sex in a multinational randomized clinical trial.

BACKGROUND AND OBJECTIVE: Worldwide, 50% of human immunodeficiency virus (HIV)-infected people are women. This study was to evaluate whether the safety and efficacy outcomes of three initial antiretroviral regimens (ARVs) differed by sex. METHODS: Antiretroviral regimen naive participants from nine countries in four continents were assigned to ARVs with efavirenz (EFV) plus lamivudine-zidovudine, atazanavir (ATV) plus didanosine (ddI)-EC/emtricitabine (FTC) or EFV plus FTC-tenofovir-DF. The primary objective was to estimate the sex difference on efficacy outcome of treatment failure defined as one of the following: 1. Time to 1st of confirmed virologic failure, 2. WHO Stage 4 progression or 3. death with hazard ratio (HR) and 95% confidence interval (CI) from adjusted Cox regression models. RESULTS: In all, 739 (47%) women and 832 (53%) men with HIV were evaluated. Women had higher pretreatment CD4+(182 vs 165 cells/mm(3); P < 0.001) and lower HIV-1 RNA (4.9 log10 vs 5.2 log10 copies/ml; P < 0.001) compared to men. Association of sex with time to regimen failure differed by treatment arm (P = 0.018). For atazanavir plus didanosine-EC plus emtricitabine, women had a longer time to treatment failure compared to men [adjusted HR (aHR) = 0.59; 95% CI 0.40-0.87]. Women were less likely to prematurely discontinue treatment prematurely (aHR = 0.74; 95% CI 0.56-0.98). Women assigned to efavirenz plus lamivudine-zidovudine were more likely to have a primary safety event compared to men (aHR = 1.49; 95% CI 1.18-1.88). CONCLUSION: Antiretroviral efficacy and safety differed by sex in this study. Consideration of potential effects of sex on antiretroviral outcomes is important for the design of future clinical trials and for HIV treatment guidelines.

Health literacy in HIV treatment: accurate understanding of key biological treatment principles is not required for good ART adherence.

Findings on the relationship between health literacy and outcomes in HIV have been inconsistent. Health literacy has previously been operationalized as general functional literacy, but has not included content knowledge about HIV disease and treatment. Semi-structured interviews with people living with HIV in 2 U.S. cities, including questions about the etiology, pathophysiology and treatment of HIV. We compared responses to biomedical conceptions. The 32 respondents were demographically diverse. Although most understood that HIV degrades the immune system, none could explain the nature of a virus, or the mechanism of antiretroviral (ARV) drug action. Fewer than half accurately reported that it is desirable to have a high CD4+ cell count and low viral load. A minority understood the concept of drug resistance. While most believed that strict adherence to ARV regimens was important to maintain health, three believed that periodic treatment interruption was beneficial, and three believed they should not take ARVs when they used alcohol or illicit drugs. Respondents generally had very limited, and often inaccurate biomedical understanding of HIV disease. Most reported good regimen adherence but did not have any mechanistic rationale for it. The failure to find a consistent relationship between health literacy and ARV adherence may be largely because most people simply follow their doctors' instructions, without the need for deep understanding.

Multiple gaps in care common among newly diagnosed HIV patients.

The objective of this study was to identify frequency and predictors of gaps in care in a longitudinal cohort of HIV-infected patients in urban New England. We conducted a retrospective cohort study in Providence, RI, of 581 newly diagnosed HIV patients >18 entering into care from 2004 to 2010, and followed their care through the end of 2011. The outcome of interest was gaps in care, defined as an interruption of medical care for >6 months. Time to the first gap was characterized using Kaplan-Meier (KM) curves. Anderson-Gill proportional hazards (AGPH) model was used to identify the risk factors of recurrent gaps in care. During the study period, 368 patients (63%) experienced at least 1 gap in care, 178 (30%) had ≥2 gaps, 84 (14.5%) had ≥3 gaps, and 21 (3.6%) died; 77% of the gaps were followed by a re-linkage with care The KM curves estimate that one-quarter of patients (95% CI = 22-29%) would experience ≥1 gap in care by Year 1; nearly one-half (CI = 45-54%) by Year 2; and 90% (CI = 93-96%) by Year 8. A prior gap was a strong predictor (HR = 2.36; CI = 2.16-2.58) of subsequent gaps; other predictors included age <25 (HR = 1.29; CI = 1.04-1.60), and no prescription of ART in first year of care (HR = 1.23; CI = 1.01-1.50). The results of this study suggest that a significant proportion of newly diagnosed HIV-infected patients will experience multiple gaps in care and yet re-engagement is possible. Interventions should focus on both prevention of gaps as well as re-engaging those lost to follow-up.

Cognitive and field testing of a new set of medication adherence self-report items for HIV care.

We conducted four rounds of cognitive testing of self-report items that included 66 sociodemographically diverse participants, then field tested the three best items from the cognitive testing in a clinic waiting room (N = 351) and in an online social networking site for men who have sex with men (N = 6,485). As part of the online survey we conducted a randomized assessment of two versions of the adherence questionnaire-one which asked about adherence to a specific antiretroviral medication, and a second which asked about adherence to their "HIV medicines" as a group. Participants were better able to respond using adjectival and adverbial scales than visual analogue or percent items. The internal consistency reliability of the three item adherence scale was 0.89. Mean scores for the two different versions of the online survey were similar (91.0 vs. 90.2, p < 0.05), suggesting that it is not necessary, in general, to ask about individual medications in an antiretroviral therapy regimen when attempting to describe overall adherence.

Jails as an opportunity to increase engagement in HIV care: findings from an observational cross-sectional study.

Linkage, engagement, retention and adherence to care are necessary steps along the HIV care continuum. Progression through these steps is essential for control of the disease and interruption of transmission. Identifying and re-engaging previously diagnosed but out-of-care patients is a priority to achieve the goals of the National HIV/AIDS strategy. Participants in the EnhanceLink cohort who were previously diagnosed HIV+ (n = 1,203) were classified as not-linked to of care and non-adherent to medication prior to incarceration by self report. Results based on multivariate models indicate that recent homelessness as well as high degrees of substance abuse correlated with those classified as not-linked to care and non-adherent to medications while having insurance was associated with being linked to care and adherent to care. The majority of detainees reported being linked to care but not currently adherent to care confirming that jails are an important site for re-engaging HIV+ individuals.

HIV testing practices among New England college health centers.

BACKGROUND: The prevalence of human immunodeficiency virus (HIV) continues to increase among certain populations including young men who have sex with men (MSM). College campuses represent a potential setting to engage young adults and institute prevention interventions including HIV testing. The purpose of this study was to evaluate testing practices for HIV and other sexually transmitted infections (STIs) on college campuses. METHODS: Medical directors at four-year residential baccalaureate college health centers in New England were surveyed from June, 2011 to September, 2011. Thirty-one interviews were completed regarding experiences with HIV testing, acute HIV infection, other STI testing, and outreach efforts targeting specific at-risk groups such as MSM. RESULTS: Among schools that responded to the survey, less than five percent of students were tested for HIV at their local college health center in the past academic year (2010-2011). Significant barriers to HIV testing included cost and availability of rapid antibody testing. One-third of college health medical directors reported that their practitioners may not feel comfortable recognizing acute HIV infection. CONCLUSIONS: Improved HIV testing practices are needed on college campuses. Programs should focus on outreach efforts targeting MSM and other at-risk populations.

Social Support Assets and Needs of Underrepresented Students Participating in Health Sciences Pathways Programs in Birmingham, Alabama.

BACKGROUND: Using the Asset Bundle Model, we sought to understand the social support assets and needs of underrepresented minority (URM) high school, undergraduate, and graduate students. SETTING: Study participants were or had participated in health sciences pathway programs at Birmingham City Schools and/or the University of Alabama at Birmingham. METHODS: We took a concurrent mixed methods approach to conduct an environmental scan of health science pathway programs in the Birmingham, AL area. Four focus groups were conducted between November 2022 and January 2023, and a 225-item online survey was administered between November 4, 2022, and February 4, 2023. Both tools collected data from high school, undergraduate, and graduate students to examine key components of existing health care pathways programs for URMs and identify barriers and facilitators to successful implementation of such programs. RESULTS: Twenty-two students participated in the focus groups, and 168 individuals responded to the survey. Both focus group participants and interview respondents were primarily URMs (eg, 68.2% and 65.7% identified as Black or African American, respectively). Survey responses and focus group discussions showed that, overall, undergraduate and graduate students programs develop more robust identities as future health care professionals through friendships and institutional supports, expand their networks more broadly through mentorship, and feel more supported by family members in their academic endeavors than high school students. CONCLUSIONS: Health science pathway programs for URMs should facilitate and bolster social supports for students, especially those in high school, to enhance persistence through education and into the workforce.

Using publicly available data to identify priority communities for a SARS-CoV-2 testing intervention in a southern U.S. state.

Background: The U.S. Southeast has a high burden of SARS-CoV-2 infections and COVID-19 disease. We used public data sources and community engagement to prioritize county selections for a precision population health intervention to promote a SARS-CoV-2 testing intervention in rural Alabama during October 2020 and March 2021. Methods: We modeled factors associated with county-level SARS-CoV-2 percent positivity using covariates thought to associate with SARS-CoV-2 acquisition risk, disease severity, and risk mitigation practices. Descriptive epidemiologic data were presented to scientific and community advisory boards to prioritize counties for a testing intervention. Results: In October 2020, SARS-CoV-2 percent positivity was not associated with any modeled factors. In March 2021, premature death rate (aRR 1.16, 95% CI 1.07, 1.25), percent Black residents (aRR 1.00, 95% CI 1.00, 1.01), preventable hospitalizations (aRR 1.03, 95% CI 1.00, 1.06), and proportion of smokers (aRR 0.231, 95% CI 0.10, 0.55) were associated with average SARS-CoV-2 percent positivity. We then ranked counties based on percent positivity, case fatality, case rates, and number of testing sites using individual variables and factor scores. Top ranking counties identified through factor analysis and univariate associations were provided to community partners who considered ongoing efforts and strength of community partnerships to promote testing to inform intervention. Conclusions: The dynamic nature of SARS-CoV-2 proved challenging for a modelling approach to inform a precision population health intervention at the county level. Epidemiological data allowed for engagement of community stakeholders implementing testing. As data sources and analytic capacities expand, engaging communities in data interpretation is vital to address diseases locally.

Risk of HIV Viral Rebound in the Era of Universal Treatment in a Multicenter Sample of Persons With HIV in Primary Care.

Background: Antiretroviral therapy (ART) is recommended for people with HIV (PWH), irrespective of CD4 cell count, to improve their health and reduce the risk of transmission to sexual partners through long-term viral suppression. We identified risk factors for viral rebound among patients with a period of stable viral suppression to inform counseling and monitoring. Methods: We conducted a multisite, retrospective study of PWH with a 2-year period of sustained viral suppression in the United States using the Centers for AIDS Research Network of Integrated Clinical Systems cohort. We used multivariable logistic regression to identify characteristics independently associated with any viral rebound (viral load [VL] ≥200 copies/mL) and sustained viral rebound (VL ≥200 copies/mL followed by a VL that was also ≥200 copies/mL within 6 months), within 2 years of follow-up. Results: Among 3496 eligible patients with a 2-year period of sustained viral suppression, most (90%) continued to have viral suppression over 2 additional years; 10% experienced viral rebound, and 4% experienced sustained viral rebound. In multivariable analyses, Black race, current smoking, integrase strand transfer inhibitor use, and 5- to 9-year duration of ART were positively associated, and being age ≥50 years was negatively associated, with any viral rebound. Only current smoking and 5- to 9-year (vs 2- to 4-year) duration of ART were positively associated, and being age ≥60 years was negatively associated, with sustained viral rebound. Conclusions: Most people retained in clinical care and with HIV viral suppression on ART will have persistent viral suppression. However, some patients may benefit from additional treatment adherence support.

Hepatitis B virus and hepatitis D virus infection in women with or at risk for HIV infection in the United States.

Hepatitis D virus (HDV) requires co-infection with hepatitis B virus (HBV). Human immunodeficiency virus (HIV) shares transmission routes with these viruses. Among 4,932 US women infected with or at-risk for HIV during 1994-2015, HBV surface antigen (HBsAg) positivity was more common in women with HIV (2.8% vs. 1.2%; p = 0.001); HDV was more common among participants enrolled during 2013-2015 (p = 0.0004) and those with resolved rather than active hepatitis C (1.9% vs. 0.5%; p = 0.02). Among HBsAg-positive women (n = 117), HDV antibody prevalence was 22% and did not vary by HIV status; HDV infection was associated with the presence of advanced fibrosis/cirrhosis at enrollment (adjusted odds ratio, 5.70; 95% confidence interval, 1.46-22.29). Our results demonstrate the importance of HDV testing in HBV-infected US women.